Expiratory Muscle Conditioning in Multiple Sclerosis Using Magnetic Stimulation
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|ClinicalTrials.gov Identifier: NCT01758224|
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : August 4, 2016
Multiple sclerosis (MS) is a primary disorder of the central nervous system that may affect motor pathways and cause muscle weakness. Respiratory complications due to respiratory muscle weakness are common in the terminal stages of MS and contribute to mortality in these patients. Respiratory muscle weakness may also impair the performance of coughing and aspiration, pneumonia, or even acute ventilatory failure may ensue. Functional magnetic stimulation (FMS) is a non-invasive method that promotes the contraction of muscles through nerve activation. Over the last few years, the study investigators have demonstrated efficacy of FMS technology for stimulating respiratory muscles in animal models, able-bodied subjects  and spinal cord injured (SCI) patients . In this study, the researchers will investigate the efficacy of using FMS technique for respiratory muscle conditioning in patients with MS. Furthermore, the investigators will also compare expiration related outcomes of FMS technique with resistive expiratory muscle training (REMT) methodology.
- FMS conditioning of the expiratory muscles can generate significant expiratory flows and pressures in patients with MS.
- FMS conditioning of expiratory muscles is more effective compared to resistive expiratory muscle training (REMT) in patients with MS.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: Functional Magnetic Stimulation Other: Resistive Expiratory Muscle Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cleveland Clinic Research Program: Expiratory Muscle Conditioning Using Functional Magnetic Stimulation for Patients With Multiple Sclerosis|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Functional Magnetic Stimulation
This group will receive magnetic stimulation of the respiratory (breathing) muscles that may improve the breathing function in subjects with MS. The magnetic stimulation protocol (plan of study) consists of a daily expiratory (breathing out) muscle conditioning program (20 minutes).
Other: Functional Magnetic Stimulation
The magnetic stimulation protocol (plan of study) consists of a daily expiratory (breathing out) muscle conditioning program (20 minutes). A magnetic coil will be placed on participant's back to stimulate the nerves related to the breathing function. Each stimulation will last two seconds and the time between each stimulation is about half a minute. The training session will begin with low intensity FMS for 20 minutes daily. The FMS stimulation intensity will gradually increase during the 6-week training period.
Other Name: FMS
Active Comparator: Resistive Expiratory Muscle Training
Participants in this group will perform breathing exercises using a resistive breathing device. The training will take place in the FMS lab. After training, participants will perform the exercise for 20 minutes daily (5days each week for 6 weeks) in their home.
Other: Resistive Expiratory Muscle Training
The REMT training will take place in the FMS lab using a standard resistive breathing device. After training, participants will perform the exercise for 20 minutes daily (5days each week for 6 weeks) in their home. Participants will wear a nose clip when performing the breathing exercise. The exercise protocol will begin with a low resistance level for 20 minutes a day. The resistance level will gradually increase during the 6-week training period.
Other Name: REMT
- Pulmonary Function Testing (PFT) [ Time Frame: At study initiation and every two weeks over a 14 week period (8 PFTs) ]Changes in participant's pulmonary (lung) function will be assessed using a non-invasive pulmonary function test (PFT).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758224
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Vernon W Lin, MD PhD||The Cleveland Clinic|